Right Size Your Documentation – What Level of Procedure Do Your Employees Need?

Last week’s blog SOPs: What happened to say what you do and do what you say? generated a great deal of discussion about SOPs and the level of documentation required.

We are all familiar with the standard documentation pyramid. The challenge becomes the number of levels built into the pyramid. The ISO Standard 10013 identified three (3) levels to the documentation pyramid:
·    1. Quality Manual – describes the quality system and how it meets the defined quality policy and objectives to the applicable standard/regulations. This quality manual should be considered the master quality plan or roadmap to demonstrate compliance with defined standards/requirements.   
·    2. Process documents – describes the activities of the individual functional areas that are required to implement the quality system.
·    3. Other quality documents (work instructions, forms, reports, etc.) – detailed work documents.
 
This standard was published in 1995. Since that time, the pyramid has been expanded into five (5) or more layers, depending on the complexity of the quality system. The second layer of the documentation pyramid is the most common area for this expansion, due to the need for a greater definition of process, and to provide more detailed guidance to the organization. These expanded layers include:
·    Policy – defines the company’s direction and requirements. Usually a very high-level document. Commonly used in larger organizations, and distinguishes the corporate policy from local or site-specific process/procedure. In many cases, the policy level can be written into the quality manual.
·    Process documents – functional flow documents describing the interactions between the various functional levels. This type of document can often be seen as flow diagrams or SIPOC (Supplier-Input-Process-Output- Customer) diagrams.  
·    SOP (Standard Operating Procedures) – describes the activities of the individual functional units needed to implement the quality system.
·    Work instructions – detailed actions performed by employees to assure compliance to a procedure or process. Only document work instructions where precise/Critical To Quality (CTQ) activities, such as tolerances, are required. Examples include manufacturing batch specific activities. It is often helpful to include photos, diagrams and pictures at this level of documentation to provide the operator enough detail to complete the task with minimal opportunity for error.  

There is no one size fits all when it comes to defining the levels of documentation required. A couple of key points to consider:
·    Do you need five (5) levels of documentation to perform every process? Particularly in a small company – three - ten (3-10) people?
·    How do you maintain the continuity between the levels of documents within the pyramid/function? When you change one level of documentation, do you review all of the other levels and related documents to ensure there are no conflicts?
·    Whatever levels of documentation you determine are appropriate for your quality system, ensure the documentation is “user friendly.”  
Right size the documentation pyramid to meet your own business needs and quality system requirements.

About the Author
B. Christine Park is a quality systems consultant with expertise in the implementation and remediation of sustainable and regulatory compliant quality systems. She has led the successful implementation of quality systems in large
corporations, as well as small startup companies. Her industry experience and background supports compliant yet practical, pragmatic quality systems. She can be contacted at 678-480-5411 and cpark928@mindspring.com a href="http://www.enkap.com/profiles/blog/cpark928@mindspring.com">http://www.enkap.com/profiles/blog/cpark928@mindspring.com>

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